510(k) K012663 ยท IZL System, X-Ray, Mobile
EASY MOVING MOBILE X-RAY UNIT (MODEL SM-HF)
| Applicant | Sedecal USA, Inc., Deer Field IL, US |
| Decision | Substantially Equivalent, Aug 31, 2001 |
| Received | Aug 13, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K012663
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 25, 2003 | Sedecal USA, Inc. Easy Moving Motor Driven Mobile X-Ray Unit, Models SM-20HF and SM-30HF; Manufactured by SEDECAL, C/Pelya 9 Pol. Ind. Rio De Janeiro, 28110 Algete (Madrid) SPAIN Terminated |
IZL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.